Portable management and monitoring system for eye drop medication regiment

ABSTRACT

Systems and methods for medication management are provided. Some embodiments provide for a portable medication management and monitoring system for eye drop instillation in ocular chronic conditions. At least one embodiment includes a device having one or more of the following elements: (a) a jacket that goes around an eye drop bottle; (b) tactile sensors to detect the user&#39;s fingers and generate data to activate the system; (c) motion sensors to detect the motion of the medication bottle when it is grabbed and moved by the user; (d) a wireless communication module to send and receive data to a computer and portable communication devices; and/or (e) a compartment for holding the electronic components.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.14/281,001, filed May 19, 2014, entitled “PORTABLE MANAGEMENT ANDMONITORING SYSTEM FOR EYE DROP MEDICATION REGIMENT,” which is a 371 ofInternational Application No. PCT/US2013/066450, filed Oct. 23, 2013,entitled “PORTABLE MANAGEMENT AND MONITORING SYSTEM FOR EYE DROPMEDICATION REGIMENT,” which is a continuation of U.S. application Ser.No. 13/844,233, filed Mar. 15, 2013, entitled “PORTABLE MANAGEMENT ANDMONITORING SYSTEM FOR EYE DROP MEDICATION REGIMENT,” which claimspriority from U.S. Provisional Application No. 61/717,559, filed Oct.23, 2012, entitled “PORTABLE MANAGEMENT AND MONITORING SYSTEM FOR EYEDROP MEDICATION REGIMENT,” all of which are incorporated by referenceherein in their entirety.

TECHNICAL FIELD

Various embodiments of the present invention generally relate tomedication management. More specifically, some embodiments of thepresent invention relate to systems and methods for portable managementand monitoring of an eye drop medication regiment.

BACKGROUND

Approximately thirty percent of medication prescriptions are neverfilled. In addition, approximately fifty percent of medications forchronic disease are not taken as prescribed. This lack of adherence hasdramatic effects on health. Non adherence has been estimated to cost theU.S. health care system $200 billion annually. In ophthalmology, theproblem of noncompliance is particularly significant in the managementof chronic conditions such as glaucoma where a strict adherence to themedication plan is vital for preventing visual loss and blindness.Almost seventy-five percent of patients admit to some form ofnoncompliant behavior, over thirty percent do not fill theirprescriptions, and nearly fifty percent discontinue prescribed dropswithin six months.

While forgetfulness is one barrier to medication adherence, it is notthe only barrier. In addition, taking the medication at the wrong time,stopping too early or taking the wrong dose also represent other seriousbarriers. Unfortunately, there are no effective systems for managingadherence to a medication plan which can be vital for preventing visualloss and/or blindness.

BRIEF DESCRIPTION OF THE DRAWINGS

Embodiments of the present invention will be described and explainedthrough the use of the accompanying drawings in which:

FIG. 1 illustrates an example of a medication management device inaccordance with one or more embodiments of the present invention;

FIG. 2 is an expanded view of a medication management device that may beused in accordance with various embodiments of the present invention;

FIG. 3 is a side view of a user tilting a medication management devicein accordance with some embodiments of the present invention;

FIG. 4 is a view of a user using a medication management device todistribute eye drops in accordance with one or more embodiments of thepresent invention;

FIG. 5 is a flowchart illustrating a set of exemplary operations forusing a medication management device in accordance with some embodimentsof the present invention;

FIG. 6 is a flowchart illustrating a set of exemplary operations fordetermining if an eye drop has been released in accordance with someembodiments of the present invention; and

FIG. 7 is a flowchart illustrating a set of exemplary operations formeasuring medication adherence and user vitals in accordance with someembodiments of the present invention.

The drawings have not necessarily been drawn to scale. For example, thedimensions of some of the elements in the figures may be expanded orreduced to help improve the understanding of the embodiments of thepresent invention. Similarly, some components and/or operations may beseparated into different blocks or combined into a single block for thepurposes of discussion of some of the embodiments of the presentinvention. Moreover, while the invention is amenable to variousmodifications and alternative forms, specific embodiments have beenshown by way of example in the drawings and are described in detailbelow. The intention, however, is not to limit the invention to theparticular embodiments described. On the contrary, the invention isintended to cover all modifications, equivalents, and alternativesfalling within the scope of the invention as defined by the appendedclaims.

DETAILED DESCRIPTION

Various embodiments of the present invention generally relate tomedication management. More specifically, some embodiments of thepresent invention relate to systems and methods for portable managementand monitoring of an eye drop medication regiment. In some embodiments,a portable medication management and monitoring system is disclosed foreye drop instillation in ocular chronic conditions. Various embodimentsof the system provide for a management care system that reminds (e.g.,with visual or audible indicators) the user of the time and date of eacheye drop instillation, notifies the user if any doses are being missed,records for medication management purposes each instillation, sendsprogress reports to the third-parties (family members or doctors), andprovides a refill notification to the pharmacist. One advantage of thereminder system provided by embodiments of the present invention is theimprovement in compliance with medication treatment routines and isadvantageous for people who struggle remembering to instill their eyedrops. The solution also improves the clinical outcomes.

Various embodiments of the device can include one or more of thefollowing components: (a) a jacket that goes around an eye drop bottle;(b) tactile sensors to detect the user's fingers and generate data toactivate the system; (c) motion sensors to detect the motion of themedication bottle when it is grabbed and moved by the user; (d) awireless communication module to send and receive data to a computer anda portable communication device; and/or (e) a compartment for holdingthe electronic components.

Various embodiments of the present invention are compatible with aweb-based medication adherence system. A user can log into the web-basedsystem and load data regarding a medication regiment manually on a website. This information can optionally be shared or sent to an eye careprovider (e.g., for tracking medication adherence) or pharmacist (e.g.,for automatic medication refills). In addition, some embodiments of thepresent invention provide for different types of external and/ordevice-based reminding systems such as automated text messaging, phonecalls, or auditory (beeper) and visual reminders such as a flashing orchanging color LED light. For example, in one embodiment, the textmessaging system may allow a profile to be created the first time a userlogs into the web-based system. The system may request or automaticallypopulate information such as a phone number or email address

Various embodiments of the present invention provide for proactive andreactive reminding systems that require users to send back confirmationreceipts (e.g., a text reply or simply an intuitive gesture using themobile phone). For example, moving the mobile phone to simulate thegesture of eye drop instillation would say, “Yes, I took my eye drop”.Engaging the patient in the process improves and sustains the motivationfor medication adherence. The system uses a small battery or can becharged on a small station.

In the following description, for the purposes of explanation, numerousspecific details are set forth in order to provide a thoroughunderstanding of embodiments of the present invention. It will beapparent, however, to one skilled in the art that embodiments of thepresent invention may be practiced without some of these specificdetails. While, for convenience, embodiments of the present inventionare described with reference to portable medication management,embodiments of the present invention are equally applicable to variousother types of liquid dispensing and tracking needs outside of themedical industry.

Moreover, the techniques introduced here can be embodied asspecial-purpose hardware (e.g., circuitry), as programmable circuitryappropriately programmed with software and/or firmware, or as acombination of special-purpose and programmable circuitry. Hence,embodiments may include a machine-readable medium having stored thereoninstructions that may be used to program a computer (or other electronicdevices) to perform a process. The machine-readable medium may include,but is not limited to, floppy diskettes, optical disks, compact discread-only memories (CD-ROMs), magneto-optical disks, ROMs, random accessmemories (RAMs), erasable programmable read-only memories (EPROMs),electrically erasable programmable read-only memories (EEPROMs),magnetic or optical cards, flash memory, or other types ofmedia/machine-readable mediums suitable for storing electronicinstructions.

TERMINOLOGY

Brief definitions of terms, abbreviations, and phrases used throughoutthis application are given below.

The terms “connected” or “coupled” and related terms are used in anoperational sense and are not necessarily limited to a direct physicalconnection or coupling. Thus, for example, two devices may be coupleddirectly, or via one or more intermediary media or devices. As anotherexample, devices may be coupled in such a way that information can bepassed therebetween, while not sharing any physical connection with oneanother. Based on the disclosure provided herein, one of ordinary skillin the art will appreciate a variety of ways in which connection orcoupling exists in accordance with the aforementioned definition.

The phrases “in some embodiments,” “according to some embodiments,” “inthe embodiments shown,” “in other embodiments,” and the like generallymean the particular feature, structure, or characteristic following thephrase is included in at least one implementation of the presentinvention, and may be included in more than one implementation. Inaddition, such phrases do not necessarily refer to the same embodimentsor different embodiments.

If the specification states a component or feature “may”, “can”,“could”, or “might” be included or have a characteristic, thatparticular component or feature is not required to be included or havethe characteristic.

The term “module” refers broadly to a software, hardware, or firmware(or any combination thereof) component. Modules are typically functionalcomponents that can generate useful data or other output using specifiedinput(s). A module may or may not be self-contained. An applicationprogram (also called an “application”) may include one or more modules,or a module can include one or more application programs.

FIG. 1 illustrates an example of a medication management device inaccordance with one or more embodiments of the present invention. Asillustrated in FIG. 1, the medication management device provides ajacket or expansion pack 100 to enclose a bottle of eye drops withinopening 110. Jacket 100 can include a wing pressure mechanism 120, atactile sensor 130, a drop sensor 140, and an electronic modulecompartment 150. Wing pressure mechanism 120 provides a mechanism forsecuring a bottle within opening 110 of jacket 100. In otherembodiments, other mechanisms may be used. For example, inserts ofdifferent sizes may be sized to fit securely within opening 110 ofjacket 100, and at the same time, provide a smaller opening for securingthe bottle. In other cases, different materials may be used to linejacket 100 that are flexible enough to allow for insertion of a bottle.

Tactile sensor 130 can be used to provide a touch input interface (e.g.,to detect the finger of a user). The user's touch can thenactivate/deactivate (i.e., turn on-off) the device. In some embodiments,the sensors can also detect and record other types of data such as pulseand heart rate. Drop detector sensor 140 can detect when a drop ofliquid leaves the bottle. Drop sensor 140 could be an optical (e.g.,LED/phototransistor) sensor capable of detecting if a drop has beenreleased from the bottle. In these cases, when a drop is released fromthe bottle, the drop will refract a beam and produce a signal on theoutput. Drop sensor 140 may be placed at the top of the expansion packand could be activated only in a specific position of the bottle toconserve power.

Electronic module compartment 150 can house one or more modules and/orcomponents (e.g., processors, communication devices, integratedelectronics, memory storage devices, batteries, etc.) of the medicationmanagement device. For example, in some embodiments, electronic modulecompartment 150 can include a gesture recognition module. The gesturerecognition module can be used for detecting and providing the hand andbottle motion and position. In order to avoid false and unwanted motionmeasurement, in some embodiments, the gesture recognition module may beactivated only when the tactile sensors detect the user's fingers'touch.

As another example, a wireless communication module can be used to sendand receive data to and from a computer and portable communicationdevices. An embedded controller module can include signal preprocessingelectronics. Still yet, the device may include Bluetooth wirelesstechnology to send and load data to a mobile device or computer.

In some embodiments, jacket 100 may have integrated electronics andcomponents embedded throughout. As illustrated in FIG. 2, electronicmodule compartment 150 can be removable from jacket 100. As a result,some embodiments provide for a plurality of jackets, each havingopenings of different sizes and lengths to hold different sized bottles.The jackets can be removed and interchanged with the electronic modulecompartment.

FIG. 3 is a side view of a user tilting a portable medication managementdevice 310 in accordance with some embodiments of the present invention.Once a bottle is placed within the device and a user begins to interactwith portable medication management device 310, various subsystems canbe activated for tracking the user's activity. For example, when theuser interacts (e.g., touches, moves, etc.) with the device, varioussensors (e.g., drop sensors) can be activated. The user tilts portablemedication management device 410 to distribute eye drops 430 from bottle420, as illustrated in FIG. 4.

FIG. 5 is a flowchart illustrating a set of exemplary operations 500 forusing a medication management device in accordance with some embodimentsof the present invention. As illustrated in FIG. 5, detection operation510 uses one or more tactile sensors to detect a touch from the user.The tactile sensors may be used to produce tactile sensor data. The datacan include information regarding amount of pressure on each sensor,length of touch, touching patterns, and/or other information. Upondetection of a touch from the user, the tactile sensor data can be usedto activate a motion-sensing subsystem within the device. In someembodiments, for example, the motion-sensing subsystem may only beactivated when a touch lasting more than a predetermined length of time(e.g., one second) is detected.

As the user moves the bottle during movement operation 530, the motionsensors are capable of detecting the bottle's motion and activating adrop sensor during activation operation 540. In some embodiments, if nomovement is detected within a certain amount of time (e.g., tenseconds), the motion detectors may be deactivated. Once the drop sensoris activated, monitoring operation 550 determines if a drop has beenreleased from the bottle. Data (e.g., number of drops, time, date, etc.)may then be transmitted to a medication adherence system or acommunications device for processing and/or tracking.

FIG. 6 is a flowchart illustrating a set of exemplary operations 600 fordetermining if an eye drop has been released in accordance with someembodiments of the present invention. As illustrated in FIG. 6, one ormore tactile sensors can be used to detect user interaction with themedication management device during detection operation 610. Inaccordance with various embodiments, the tactile sensors may be activelymonitoring for input from the user. In other embodiments, the tactilesensors may be a mechanical switch or button that requires a specifictype of pressure, motion, or interaction in order to trigger a detectionevent having a set of tactile data. This data can be used to activateone or more drop sensors during activation operation 620. Determinationoperation 630 then determines if the drop sensor detects a drop beingreleased from the bottle. Information regarding the drop (e.g.,medication type, time of day, date, etc.) can then be transmitted to amedication adherence system during output operation 640. Outputoperation 640 may send updates automatically on a predetermined scheduleor upon detection of an event. In some cases, wireless transmissions(e.g., cellular, Bluetooth, etc.) can be used to transmit the data.

FIG. 7 is a flowchart illustrating a set of exemplary operations formeasuring medication adherence and user vitals in accordance with someembodiments of the present invention. As illustrated in FIG. 7,detection operation 710 uses one or more tactile sensors to detect atouch from the user. The tactile sensors may be used to produce tactilesensor data. As discussed above, the data can include informationregarding amount of pressure on each sensor, length of touch, touchingpatterns, and/or other information. Upon detection of the touch from theuser, the tactile sensor data can be used to activate a motion-sensingsubsystem within the device during motion-sensing activation operation720.

As the user moves the bottle during movement operation 730, the motionsensors are capable of detecting the bottle's motion and activating adrop sensor during activation operation 740. Once the drop sensor isactivated, monitoring operation 750 determines if a drop has beenreleased from the bottle. Drop data (e.g., number of drops, time, date,etc.) may then be transmitted to a medication adherence system or acommunications device for processing and/or tracking.

If motion-sensing operation 720 does not detect any movement of thebottle by the user, holding operation 770 determines if the usercontinues to hold the one or more tactile sensors (e.g., for more thanfive or ten seconds). Once a holding threshold has been exceeded, apulse rate measuring algorithm may be activated during pulse rateactivation operation 780 to measure the user's pulse rate, heart rate,or even blood chemistry. The pulse rate data can then be transmitted toanother device and/or monitoring system.

Embodiments of the present invention include various steps andoperations, which have been described above. A variety of these stepsand operations may be performed by hardware components or may beembodied in machine-executable instructions, which may be used to causea general-purpose or special-purpose processor programmed with theinstructions to perform the steps. Alternatively, the steps may beperformed by a combination of hardware, software, and/or firmware.

In conclusion, various embodiments of the present invention providenovel systems, methods and arrangements for management and monitoring ofan eye drop medication regiment. While detailed descriptions of one ormore embodiments of the invention have been given above, variousalternatives, modifications, and equivalents will be apparent to thoseskilled in the art without varying from the spirit of the invention. Forexample, while the embodiments described above refer to particularfeatures, the scope of this invention also includes embodiments havingdifferent combinations of features and embodiments that do not includeall of the described features.

What is claimed is:
 1. A medication management device comprising: ajacket configured to hold a bottle of eye drops; means for sensing adrop of liquid leaving the bottle; means for recording allocation datathat indicates whether the drop of liquid has left the bottle; aprocessor coupled to a storage medium; the storage medium comprisinginstructions for: storing medication regimen data; storing theallocation data; and comparing the allocation data to the medicationregimen data.
 2. The medication management device of claim 1, whereinthe medication regimen data comprises one or more of a time, a date, aquantity, or a type of medication a user should administer.
 3. Themedication management device of claim 2, further comprising: means forgenerating a reminder the user should place the drop of liquid within aneye of the user.
 4. The medication device of claim 3, wherein the meansfor generating the reminder comprises one or more light-emitting diodesthat provide a visual reminder to the user.
 5. The medication device ofclaim 3, wherein the means for generating the reminder comprises one ormore speakers that provide an auditory reminder to the user.
 6. Themedication management device of claim 1, the storage medium furthercomprising instructions for: generating an adherence report based on thecomparison of the allocation data to the medication regimen data.
 7. Themedication management device of claim 6, further comprising: a wirelesscommunication module configured to transmit the medication regimen data,the allocation data, the adherence report, or any combination thereof toa communications device.
 8. The medication management device of claim 7,wherein the communications device is associated with an eye careprovider, a hospital, or a pharmacy.
 9. The medication management deviceof claim 7, the storage medium further comprising instructions for:generating a refill notification when a number of remaining doses in thebottle falls below a predetermined threshold.
 10. The medicationmanagement device of claim 9, wherein the wireless communication moduleis further configured to transmit the refill notification to thecommunications device.
 11. A medication adherence system comprising: amedication management device comprising: a jacket configured to hold abottle of eye drops; a drop sensor configured to record allocation dataregarding a drop of liquid leaving the bottle; and a wirelesscommunication module configured to transmit the allocation data to acommunications device configured to receive the allocation data from themedication management device, display the allocation data to a user viaa medication management portal, and permit the user to manually entersupplementary data via the medication management portal.
 12. Themedication adherence system of claim 11, wherein the communicationsdevice is further configured to send the allocation data, thesupplementary data, or both to a second communications device associatedwith an eye care provider, a hospital, or a pharmacist.
 13. Themedication adherence system of claim 11, wherein the communicationsdevice is further configured to remind the user a dose of medicationshould be administered.
 14. The medication adherence system of claim 13,wherein the communications device is a mobile device or a computer. 15.The medication adherence system of claim 14, wherein the medicationmanagement portal is displayed to the user via a mobile application, aweb-based application, or a web browser.
 16. The medication adherencesystem of claim 11, wherein the supplementary data comprises one or moreof a time, a date, a quantity, or a type of medication that wasadministered by the user.
 17. The medication adherence system of claim11, wherein the supplementary data comprises a confirmation receipt thatindicates whether medication was administered, the confirmation receiptcomprising a textual response, an audible response, a gestural response,or any combination thereof.
 18. The medication adherence system of claim11, wherein the communications device is coupled to a storage mediumcomprising medication regimen data, the medication regimen datacomprising one or more of a time, a date, a quantity, or a type ofmedication the user should administer.
 19. The medication adherencesystem of claim 18, wherein the medication management portal isconfigured to generate an adherence report based on a comparison of theallocation data and the supplementary data to the medication regimendata.
 20. A medication management device comprising: a jacket configuredto hold a bottle of eye drops, wherein the jacket comprises a motionsensor to detect movement of the jacket and the bottle; a monitoringmodule configured to activate a drop sensor upon the motion sensordetecting movement, wherein the drop sensor records data regarding adrop of liquid leaving the bottle; a storage medium having storedthereon medication regimen data that comprises one or more of a time, adate, a quantity, or a type of medication a user should administer viathe medication management device; and a wireless communication moduleconfigured to send a reminder to administer medication to the user,wherein the reminder is based on the medication regimen data.
 21. Themedication management device of claim 20, further comprising: a tactilesensor configured to activate and deactivate the motion sensor; apressure sensor arranged such that activation of the pressure sensorindicates the bottle has been inserted into the jacket; and a removableelectronic compartment comprising the monitoring module, the storagemedium, and the wireless communication module.
 22. The medicationmanagement device of claim 20, wherein the reminder is a text message ora phone call transmitted to a communications device associated with theuser.
 23. The medication management device of claim 21, wherein theremovable electronic compartment can be attached to any of a pluralityof jackets, the plurality of jackets having openings of different sizesand lengths to hold different sized bottles.